FDA.reportPublic FDA data

MAUDE MDR 3777371

MDR report key
3777371
Report number
3006579682-2014-00001
Event key
0
Event type
3
Date of event
2014-04-16
Date received
2014-04-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. LUCA SALVATORE
Address
RUNDETURMSTR. 12 DARMSTADT, HESSEN 64283 GM
Phone
151-151-1519
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VERISUITE 1.8PARTICLE THERAPY - PATIENT POSITIONING VERIFICATION SOFTWAREMEDCOM GMBHLHN1.8Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-04-290

Event Narratives#

D

Patient 1

ON (B)(4) 2014, MEDCOM HAS LEARNT ABOUT A SOFTWARE DEFECT RELATED TO VERISUITE 1.8 VERSION B600.4. THE DEFECT CAUSES MALFUNCTIONING OF THE SOFTWARE WHEN A SLICE OF THE PLANNING CT IS MISSING OR DUPLICATED. VERISUITE WILL DISPLAY A MESSAGE IN CASE OF OMITTED OR DUPLICATE SLICES (A DUPLICATE SLICE WILL BE OMITTED). HOWEVER, WHEN THE USER CONTINUES PATIENT POSITION VERIFICATION BASED ON CT DATASETS WITH DUPLICATE OR MISSING SLICES, THE SOFTWARE DEFECT MAY LEAD TO A SHIFT OF THE ISOCENTER POSITION AND THUS TO A WRONG CORRECTION VECTOR AND INCORRECT PATIENT POSITIONING.

N

Patient 1

ALL AFFECTED SITES HAVE BEEN CONTACTED ON (B)(4) 2014 VIA A FIELD SAFETY NOTICE (SEE ATTACHED). THE FIELD SAFETY NOTICE RECOMMENDS THE USER NOT TO CONTINUE TREATMENT IF VERISUITE INFORMS ABOUT MISSING SLICES VIA AN ONSCREEN MESSAGE, I.E. IF THE CT DATASET WAS NOT COMPLETELY TRANSFERRED TO VERISUITE. THE USER SHALL RESTART VERISUITE AND RELOAD THE COMPLETE DATASET IN CASE OF MISSING SLICES. THE AFFECTED SITES ARE: (B)(4). THE SITES WERE ALSO INFORMED IN THE FIELD SAFETY NOTICE TO UPGRADE AS SOON AS POSSIBLE TO THE NEWEST VERISUITE VERSION 1.8 B641.3/.4, WHICH IS AVAILABLE AND INCLUDES A BUG FIX FOR THE REPORTED PROBLEM.